Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome Patients

Recruiting

• Conditions: Complex Regional Pain Syndromes
• Interventions: Drug: Buprenorphine

• Registration Number: NCT03977012
• Lead Sponsor: Seoul National University Hospital

Brief Summary

In the present study, we aim to investigate the effect of buprenorphine on neuroinflammation in patients with complex regional pain syndrome, using \[11C\]-(R)-PK11195 PET.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-06-05
• Study First Posted: 2019-06-06
• Study Start: 2019-06-11
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-14
• Primary Completion: 2024-04-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients diagnosed with complex regional pain syndrome Type I (Budapest Criteria) and persistent back pain (VAS ≥ 4).
2. Patients who can stop benzodiazepine treatment 2 weeks before study
3. Patients who initially decided to use buprenorphine according to clinical judgment
4. Patients who are able to understand the purpose and procedure of the study

Exclusion Criteria

1. Patients with an impaired cognitive function such as psychosis, dementia, or mental retardation
2. Patients with neurologic disease, cerebrovascular disease, history of brain tumor, history of severe head trauma, history of convulsive disease
3. Patients with cardiovascular disease, liver, respiratory or renal dysfunction
4. Patients with biliary disease
5. Patients who could not undergo the PET/magnetic resonance imaging (MRI) process.
6. Patients who have a risk of suicide or show aggressive behavior
7. Patients who have drug dependence (DSM-IV criteria) or history (past 6 months or older)
8. Employees of researchers or clinical research institutes
9. Patients with hypersensitivity or contraindication to buprenorphine

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with CRPS Type I	Buprenorphine	Patients diagnosed with Complex Regional Pain Syndrome Type I who are anticipated to recieve a 8 weeks regime of buprenorphine as a part of routine medical care. -drug name: norspan patch 5\~20 mcg dosage form: patch frequency: every weeks duration: 8 weeks

Primary Outcome Measures

Name	Time	Method
Changes in neuroinflammation	baseline, 8 weeks	\[11C\]-(R)-PK11195 PET distribution volume ratio (DVR)

Secondary Outcome Measures

Name	Time	Method
Morphine equivalent	baseline, 8 weeks	narcotic analgesic dosage
Physical test(1)	baseline, 8 weeks	blood test
Physical test(2)	baseline, 8 weeks	urine test
Physical test(3)	baseline, 8 weeks	Electrocardiogram(ECG) test (pulse rate)
Physical test(4)	baseline, 8 weeks	pulse measurement
Physical test(5)	baseline, 8 weeks	blood pressure measurement
Self-reported questionnaire(3)	baseline, 8 weeks	Short Form McGill Pain Questionnaire(SF-MPQ)/ 'a' subscale score: 0\~45, The higher the score, the more painful/ 'b' subscale score, 0\~10, The higher the score, the more painful/ 'c' subscale score, 0\~5, The higher the score, the more painful
Self-reported questionnaire(1)	baseline, 8 weeks	Beck Depression Index(BDI)/ total score: 0\~63, The higher the score, the more depressed
Self-reported questionnaire(2)	baseline, 8 weeks	Beck Anxiety Index(BAI)/ total score: 0\~63, The higher the score, the more anxiety
Self-reported questionnaire(4)	baseline, 8 weeks	Pain Catastrophizing Scale/ total score: 0\~52, The higher the score, the more pain Catastrophizing

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of